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NCT06594887NARecruiting

Rectal Spacers Use in Prostate Cancer Radiation Therapy

Princeton ProCure management, LLC.

Start Date

9/6/2024

Completion Date

12/1/2025

Summary

This prospective, 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for Proton Beam Therapy (PBT). Up to 50 subjects will be enrolled in this study. Study visits will include screening, spacer placement, treatment planning, end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria 1. Subjects greater than 18 years old with prostate cancer 2. Subjects must have histologically confirmed adenocarcinoma of the prostate with biopsy taken within 12 months and must be planned to undergo proton beam therapy with rectal spacer 3. Subjects must have clinical stage T1-T3 with no posterior extra capsular extension of the prostate cancer 4. PSA less than or equal to 20 ng/mL 5. Gleason Score less than or equal to 7 6. Capacity to comprehend and readiness to sign a written informed consent form Exclusion Criteria 1. Planned Pelvic lymph node radiotherapy. 2. Metastatic disease. 3. Prior local prostate cancer therapy 4. Active Inflammatory bowel disease requiring treatment with steroids. 5. Prior radical prostatectomy. 6. Active urinary tract infection. 7. Acute or chronic inflammation or infection of the prostate.

Interventions

DEVICE

SpaceOAR Vue

DEVICE

BioProtect Balloon Implant System

Interested in This Trial?

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Conditions

Prostate Cancer

Locations

Procure Proton Therapy Center

Somerset, New Jersey 08873

United States